FDA Approves First Biosimilar to Treat Multiple Sclerosis

FDA Approves Eylea HD (aflibercept) Injection 8mg for Treatment of wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
August 18, 2023
FDA Approves Aphexda™ (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma
September 11, 2023
FDA Approves Eylea HD (aflibercept) Injection 8mg for Treatment of wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
August 18, 2023
FDA Approves Aphexda™ (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma
September 11, 2023

August 24, 2023 - The U.S. Food and Drug Administration has approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Tyruko (natalizumab-site) is an injectable integrin receptor antagonist that is a biosimilar to Tysabri (natalizumab) that may be used to treat adults with relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) or moderate to severe Crohn's disease (usually after other treatments have been tried).

Patients who are allergic to natalizumab or have ever had PML should not receive Tyruko.

Tyruko is only available from a certified pharmacy under a special program called the Tyruko REMS Program. Patients must be registered in the program and understand the risks and benefits of taking this medicine.

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